Lung cancer is the number one cause of cancer mortality globally and has an estimated incidence of 1.3 million new cases every year. In the U.S. it is the second most commonly diagnosed cancer, over 200,000 people are diagnosed annually with this disease and it is the leading cause of cancer-related deaths, with almost 160,000 people estimated to succumb to the disease each year. Approximately 80% to 85% of the newly diagnosed cases of lung cancer are non-small cell lung cancer (NSCLC) (adenocarcinoma, squamous carcinoma and large cell carcinoma) and 15% to 20% are small cell lung carcinoma. Surgical resection is the most consistent and successful option for cure, but requires completely resectable cancer, which is not feasible for most patients since 70% of patients present with unresectable and/or non-curable disease.
Advances in cancer diagnosis and treatment during the last several decades have provided substantial improvements in outcomes, but some tumors, such as NSCLC, remain difficult to diagnose at an early disease stage and overall survival (OS) continues to be poor for patients who first present with advanced disease or who progress after initial treatment. Additional therapies are needed for these patients